Non-Incised Papillae Surgical Approach (NIPSA) With and Without Graft

Periodontitis Clinical Trial

— NIPSAGRAFT  

Official title:

Clinical and Radiographic Outcomes of the Apical Approach in Periodontal Surgery Reconstruction With and Without Graft Materials: Non-Incised Papillae Surgical Approach (NIPSA). A Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04712630
• Other study ID #: 2441/2019
• Status: Completed
• Phase: N/A
• Start date: September 9, 2019
• Est. completion date: December 30, 2020

Study information

• Verified date: January 2021
• Source: Universidad de Murcia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study compared the clinical outcomes of the non-incised papila surgical approach (NIPSA) alone and with grafting biomaterial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 30, 2020
• Est. primary completion date: September 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients diagnosed with periodontitis.
• plaque index and bleeding index of < 30%.
• periodontal lesions with pocket probing depth > 5 mm.
• intrabony defect > 3 mm.
• intrabony defect configuration including a 1 and/or 2-wall component, always involving the buccal wall.

Exclusion Criteria:

• patients with systemic diseases that contraindicated treatment.
• third molars.
• teeth with incorrect endodontic or restorative treatment.

Related Conditions & MeSH terms

• Periodontal Attachment Loss
• Periodontal Diseases
• Periodontal Pocket
• Periodontitis

Intervention

Procedure:
• Non-incised papila surgical approach without grafting biomaterial
Periodontal reconstructive surgery
• Non-incised papila surgical approach with grafting biomaterial
Periodontal reconstructive surgery

Locations

Country	Name	City	State
Spain	Centro Odontologico Del Sureste Slp	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Murcia

Country where clinical trial is conducted

Spain, 

References & Publications (3)

Moreno Rodriguez JA, Caffesse RG. Nonincised Papillae Surgical Approach (NIPSA) in Periodontal Regeneration: Preliminary Results of a Case Series. Int J Periodontics Restorative Dent. 2018;38(Suppl):s105-s111. doi: 10.11607/prd.3195. — View Citation

Moreno Rodríguez JA, Ortiz Ruiz AJ, Caffesse RG. Periodontal reconstructive surgery of deep intraosseous defects using an apical approach. Non-incised papillae surgical approach (NIPSA): A retrospective cohort study. J Periodontol. 2019 May;90(5):454-464. doi: 10.1002/JPER.18-0405. Epub 2018 Nov 28. — View Citation

Moreno Rodríguez JA, Ortiz Ruiz AJ, Caffesse RG. Supra-alveolar attachment gain in the treatment of combined intra-suprabony periodontal defects by non-incised papillae surgical approach. J Clin Periodontol. 2019 Sep;46(9):927-936. doi: 10.1111/jcpe.13158. Epub 2019 Jul 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Probing pocket depth (PD)	Probing pocket depth will be assessed with a periodontal probe, measured in mm from the gingival margin to the bottom of the pocket	12 months
Primary	Clinical attachment level (CAL)	Clinical attachment level will be assessed with a periodontal probe, measured in mm from the cementoenamel junction (CEJ) to the bottom of the pocket.	12 months
Primary	Recession (REC)	Recession, will be assessed with a periodontal probe, measured in mmm on the buccal aspect, from the CEJ to the gingival margin zenith.	12 months
Primary	Location of the tip of the papillae (TP)	Location of the tip of the papillae. Taking as reference the level of the mid-axis of the tooth, will be measured the distance from the CEJ at the zenith of the tooth to the tip of the papilla. A positive value will be recorded when the tip of the papillae is located coronally to the CEJ and a negative value otherwise.; This outcome will be assessed with a periodontal probe and measured in mm.	12 months
Primary	Keratinized tissue width (KT)	Keratinized tissue width will be assessed with a periodontal probe, measured in mm on the buccal aspect, from the gingival margin to the mucogingival line.	12 months
Primary	Bleeding on probing	Bleeding on probing could be positive or negative.	12 months
Secondary	Supra-alveolar attachment gain (SUPRA-AG)	Subtracting the 12-month CAL from the intra-surgically BC-CEJ will provide the SUPRA-AG result.	12 months
Secondary	Wound closure (WC)	Complete wound closure (CWC = 2) Incomplete wound closure (IWC = 1) necrosis (NT = 0).	1 week